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Ampere™ Current™

by Abbott Medical 4 variants

Part of a family of 9 devices: see the family page

Ref PFA-GEN-FS10

Ampere™ Current™ (PFA-GEN-FS10) is a Class IIb device made by Abbott Medical, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 5414734ABC00456P), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414734ABC00456P Basic UDI-DI 05415067055026UDI-DIDate24 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
PFA Generator
Model / reference
PFA-GEN-FS10
Primary DI / UDI-DI
05415067055026
Basic UDI-DI
5414734ABC00456P
EMDN code
Z12059011 Cardiac ablation equipment
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000033655
Authorised representative
Abbott Medical BE-AR-000008744

Similar devices in this category

Other devices filed under CARDIAC ABLATION EQUIPMENT.

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Properties

  • Measuring function
Other properties (13, all answered No)